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Online sleep therapy program for people with long-lasting insomnia

Tests a digital sleep therapy program in adults with chronic insomnia.

Key facts

Who runs it
WELT corp
Where
South Korea5 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Digital CBT-I for Chronic Insomnia
Status
Not yet recruiting
People taking part
120 people, planned
Started
Jan 2025
Planned end
Mar 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • digital CBT-I
Record updated
19 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting insomnia to test a digital CBT-I program, a smartphone-based talking-therapy approach for sleep. Some people start right away, others wait.

Age
19 years and older
Sex
All sexes
Disease stage
Insomnia disorder by ICD-10 criteria, with symptoms for 3 months or longer and an Insomnia Severity Index (ISI) score of 8 or higher.
Earlier treatment
People cannot join if they had non-drug insomnia treatment (such as CBT-I, light therapy or traditional medicine for sleep) in the past 3 months. No changes to sleep, mood, seizure, anxiety or antipsychotic medicines in the past 3 months, and no as-needed sleep medicines.

Main reasons for not taking part

  • Another sleep disorder with current symptoms, such as sleep apnea, restless legs or narcolepsy
  • Active physical illness that limits daily life, unstable health or life expectancy under 6 months
  • Shift work
  • Pregnant or planning pregnancy during the study
  • Not fluent in Korean or unable to use smartphone apps on their own

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Meets diagnostic criteria for insomnia disorder according to the International Classification of Diseases, 10th Revision (ICD-10), including: F51: Nonorganic sleep disorders; G47: Sleep disorders
  • Has experienced insomnia symptoms for 3 months or longer
  • Scores 8 or higher on the Insomnia Severity Index (ISI)
  • Oral and written fluency in Korean
  • Owns a smartphone and is independently able to use apps on a smartphone
  • Voluntarily agrees to participate in this clinical study and provides signed informed consent

Who cannot take part

  • Currently receiving non-pharmacological treatments for insomnia (e.g., CBT-I, light therapy, traditional medicine for sleep) within the past 3 months from screening
  • Adjustments in schedule or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within the past 3 months, or use of PRN (as needed) prescribed sleep medications
  • Diagnosed with other sleep disorders aside from insomnia and currently symptomatic, such as:; Obstructive sleep apnea (G47.30); Sleep behavior disorders; Restless leg syndrome (G28.8); Narcolepsy (G47.4)
  • Has an active, ongoing physical illness that impedes daily functioning, such as:; Congestive heart failure; Chronic obstructive pulmonary disease (COPD); Acute pain; Neurological disorders (e.g., cerebrovascular disease); Neurodegenerative disorders (e.g., dementia, multiple sclerosis); Unstable medical conditions or life expectancy of less than 6 months
  • Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
  • Engaged in shift work
  • Pregnant individuals or those planning to become pregnant during the study period

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.

The 2 groups in the trial

  • digital CBT-ITreatment being tested
  • Waitlist ControlNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multi-Site, Randomized, Wait-List Controlled Trial to Assess the Effectiveness and Safety of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) in Patients with Chronic Insomnia
Plain-language title
Online sleep therapy program for people with long-lasting insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
19 November 2024